Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10
FDA device recall Z-1781-2013 · posted 2013-07-20 · Terminated
Recall details
- Recalling firm
- Myoscience Inc
- Reason for recall
- The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
- Action taken
- Myoscience representatives visited both affected sites on June 14, 2013 and relabeled the product in person. Neither site had used the product and was unaffected by the relabeling. No formal communication was issued.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GXH
- Quantity affected
- 3 units
- Distribution
- US distribution including CA and ID.
- Date initiated
- 2013-06-21
- Date posted
- 2013-07-20
- Date terminated
- 2014-07-15
- Location
- Redwood City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRYO-TOUCH IV (K123516) | Myoscience, Inc. | 2013-01-10 |